Re: FDA (b)anality

Subject: Re: FDA (b)anality
From: Bill Swallow <techcommdood -at- gmail -dot- com>
To: salt -dot- morton -at- gmail -dot- com
Date: Mon, 9 Jan 2012 13:51:26 -0500

Isn't it your regulatory affairs guy's job to decide these things so
your company is compliant with the industry and the laws surrounding
it? If the FDA insists you use the statement, then you likely need to
use it as-provided. Any changes would need to be approved by the FDA
else they could find your company at fault.

On Mon, Jan 9, 2012 at 12:04 PM, Chris Morton <salt -dot- morton -at- gmail -dot- com> wrote:
> My company has a software solution that is subject to FDA
> approval/scrutiny. That entity insists that we use the following cautionary
> statement in our user manual:
>
> CAUTION: Federal law restricts this device to the sale by, or on the order
> of, a physician.
>
>
> Because the software is not a device, I modified the statement to read:
>
> CAUTION: Federal law restricts this product to the sale by, or on the order
> of, a physician.
>
>
> Now our regulatory affairs guy has a pickle up his _____ and is hassling me
> over the change. I believe that no one can, or will, bother us about this
> minor modification.
>
> What are your thoughts about this?

--
Bill Swallow

Twitter: @techcommdood
Blog: http://techcommdood.com
LinkedIn: http://www.linkedin.com/in/techcommdood
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Create and publish documentation through multiple channels with Doc-To-Help.
Choose your authoring formats and get any output you may need. Try
Doc-To-Help, now with MS SharePoint integration, free for 30-days.
http://www.doctohelp.com

---
You are currently subscribed to TECHWR-L as archive -at- web -dot- techwr-l -dot- com -dot-

To unsubscribe send a blank email to
techwr-l-leave -at- lists -dot- techwr-l -dot- com
or visit http://lists.techwr-l.com/mailman/options/techwr-l/archive%40web.techwr-l.com


To subscribe, send a blank email to techwr-l-join -at- lists -dot- techwr-l -dot- com

Send administrative questions to admin -at- techwr-l -dot- com -dot- Visit
http://www.techwhirl.com/email-discussion-groups/ for more resources and info.

Looking for articles on Technical Communications? Head over to our online magazine at http://techwhirl.com

Looking for the archived Techwr-l email discussions? Search our public email archives @ http://techwr-l.com/archives


Follow-Ups:

References:
FDA (b)anality: From: Chris Morton

Previous by Author: Re: ANONYMOUS POST: Staffing with unskilled workers
Next by Author: Re: MS OneNote uses for tech comm
Previous by Thread: RE: FDA (b)anality
Next by Thread: Re: FDA (b)anality


What this post helpful? Share it with friends and colleagues:


Sponsored Ads